The development of needleless intravenous (IV) administrative systems began in the 1990s to protect against needle stick injuries, which proved dangerous due to the increased spread of blood-borne diseases. The IV systems also provided a means for connecting multiple medicines to a patient without additional needles, thus aiding healthcare professionals and easing patient discomfort.
Unfortunately, these IV systems lead to an estimated 250,000 IV device-related bloodstream infections (BSIs) each year in the United States. Each case has an attributable mortality rate of between 12 and 25 percent. It is estimated that these preventable infections make up 4% of medical malpractice claims on doctors and cause hospitals to lose an estimated $9B annually because of non-reimbursed litigation costs.
In intensive care units (ICUs), bloodstream infections (BSIs) caused by bacterial contamination of the connector hubs in central venous catheter systems, or central line systems, (central line-associate bloodstream infections, CLABSI) are prevalent and yet avoidable. Although CLABSIs are listed as “Never events” by Medicare due to their preventability, in the United States, over 40,000 people are infected by CLABSIs annually, of which over 10,000 die. An average case of CLABSI costs the hospital an estimated $46,000.
A majority of CLABSIs are caused by bacteria introduced into the patient's bloodstream via contamination of the system ports. Every port on the system including injection ports into bags or bottles, injection ports on administration sets, needless connectors, and the hub of the catheter itself are a potential entry point for infection. Contamination occurs when bacteria migrate from the skin-catheter interface, along the length of the catheter, down the lumens, and finally settle on the system ports. The system ports provide a safe and nutritious environment for the bacteria to colonize, and within 3-5 days, the bacteria may form a biofilm. Biofilm organisms are far more resistant to antimicrobial agents than are organisms in suspension, and biofilms exhibit strong adherence to the surface of habitable environments. Combating this occurrence requires routine connector disinfection using not only effective antimicrobial agents, but also a mechanical force component to penetrate the biofilm and break surface adhesion.
The “Scrub the Hub” (STH) protocol issued by the Center for Disease Control (CDC) establishes an approach to clean ports to eliminate the risk of BSIs. Typically, alcohol- or chlorhexidine-soaked swabs or wipes are used to abrasively scrub the components of an IV system for a given period of time to remove viruses, bacteria, yeast, fungi, and other biofilms that can cause BSIs.
Unfortunately, research suggests that IV systems often are not scrubbed for the recommended duration or with the proper amount of friction to remove biofilms. For example, the STH protocol recommends cleaning IV ports with swabs or wipes for at least 15 seconds and some facilities recommend cleaning for 30 seconds, but current estimates reveal that most healthcare professionals clean the IV ports for approximately nine seconds.
Previous attempts to reduce the number of CLABSI incidents include a variety of approaches including addressing both behavioral and technological issues. Because every port on the system provides an entry point for infection, there are many different potential CLABSI incident triggers. Previous attempted solutions include, for example, protocol changes, modifications to the ports themselves, port caps containing disinfectant, chemical changes in the disinfecting solutions used in wipes (e.g., using chlorhexideine or povidone-iodine in place of or addition to isopropyl alcohol), port cleaners specialized for certain types of system ports, and color changing wipes. Despite these attempts, CLABSI incidents persist.
There is a need, therefore, for a user-friendly, low-cost, more efficient scrubbing product that is capable of effectively disinfecting the variety of CVC system ports.